VNS Therapy (Vagus Nerve Stimulation)

http://www.reuters.com/article/2014/08/14/us-people-robinwilliams-idUSKBN0GE1YQ20140814

Robin Williams suffered from early Parkinson's at death: widow

By Piya Sinha-Roy and Eric Kelsey

LOS ANGELES Thu Aug 14, 2014 5:54pm EDT

3 Comments

A woman takes a picture of a mural depicting late actor Robin Williams in Belgrade, August 13, 2014.

Credit: Reuters/Marko Djurica

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LOS ANGELES (Reuters) - Robin Williams was sober but suffering from the early stages of Parkinson's disease as well as severe depression and anxiety at the time of his apparent suicide, the actor's widow said in a statement on Thursday.

Susan Schneider said Williams "was not yet ready to share publicly" his struggles with Parkinson's, an incurable and debilitating nervous system disorder that causes tremors and slowness of movement.

"It is our hope in the wake of Robin's tragic passing, that others will find the strength to seek the care and support they need to treat whatever battles they are facing so they may feel less afraid," Schneider said in the statement.

The 63-year-old Oscar-winning comedic virtuoso, whose madcap style and dramatic versatility made him one of film and television's top stars, was found hanged at his Tiburon, California, home north of San Francisco on Monday.

The news that the comedian also suffered Parkinson's disease has drawn attention to the correlation between the disorder and depression.

"While a diagnosis of any serious disease can be overwhelming, Parkinson's and depression can go hand in hand," the National Parkinson Foundation said in a statement following Schneider's announcement.

"Depression affects quality of life more than the motor impairments of the disease," the foundation said, adding that more than half of those who suffer from Parkinson's also experience clinical depression as part of the disease.

Actor Michael J. Fox, boxer Muhammad Ali and singer Linda Ronstadt have all be diagnosed with Parkinson's. Ronstadt said last year that the disease had robbed her of her singing voice.

Between 50,000 and 60,000 people are diagnosed with Parkinson's each year in the United States. It typically affects people over 50 years old.

Williams, whose starring roles included "Mrs. Doubtfire" and "Good Will Hunting," had been open about his struggles with alcohol and had gone to a Minnesota rehabilitation center this summer to "fine-tune" his sobriety, his publicist said in July.

Friends of the comedian, who first shot to prominence as a friendly alien in late 1970s TV series "Mork & Mindy," described Williams as a man who masked his depression and thrived from performing for a crowd.

Williams' death, which has touched off a national conversation about suicide and depression, shook Hollywood and generations of fans.

U.S. President Barack Obama called him a "one of a kind" actor while directors and colleagues noted his humble nature, generosity and talent as one the most inventive comedians of his era.

"Since his passing, all of us who loved Robin have found some solace in the tremendous outpouring of affection and admiration for him from the millions of people whose lives he touched," Schneider said.

"His greatest legacy, besides his three children, is the joy and happiness he offered to others, particularly to those fighting personal battles," she added in the statement.

Funeral arrangements are pending, and a full toxicology report will take two to six weeks, local officials said.

(Editing by Jonathan Oatis)

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Robin Williams Death Inspires 'Coming Out' About Depression

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Thursday, August 14, 2014 1:15 PM
To: Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services
Subject: Robin Williams Death Inspires 'Coming Out' About Depression

Dear Madam Secretary Burwell,

So the death of actor/comedian Robin Williams sparks discussion about depression.

I think it’s extremely sad that such a brilliant talent is lost to us and it takes his death to evoke discussion as to the seriousness of severe depression and mental health issues. On the other hand I’ve been at it for some 50 years. Worse is the fact I’m still at it and can you believe even worse yet, VNS Therapy for Depression, an FDA approved therapy is being denied medical insurance coverage to a group of volunteer study subjects and patients who are and have benefited from this therapy like no other.

What does it take to make you understand and your symphony of subordinates who can’t seem to hit the right notes to right the criminal wrong and injustice you folks have perpetrated against this group of patients? How much effort does it really take for you to sign a “Compassionate Use” document to see that this group of patients is able to maintain their wellness? Does it take another suicide of a lesser known individual whose attention you’d probably never notice to die because you lack understanding of what CMS has done to these volunteer study subjects and patients?

This is not an issue of politics or number crunching bureaucratic medical experts sitting at their computer screens without ever having examined a patient. It is an issue of maintaining life of giving these implanted patients the ability to continue with a therapy that has proven to be beneficial to them as acknowledged by the patients as well as their attending physicians and to remove them from the precipice of death.

Please tell me; just what it takes for you or anyone in your bureaucracy to understand the dire need for a treatment that finally works for these patients. The fact is that the trillions of dollars our country has spent on conventional treatments for these patients that don’t work is not the answer. But when patients come forward and tell their physicians who observe, monitor and agree that they’ve finally found a treatment such as VNS Therapy that works and you and your organization and the health insurance industry deny medical coverage; to me it is an example of absolute unadulterated and sheer stupidity despite your educations and advanced degrees.

Just ask the patients, their families, loved ones and their attending physicians. No advanced degrees neither high speed number crunching computer systems required to evaluate the difference in the lives of those patients who have benefited from the VNS Therapy for Depression. Nor or month, 6 month or year of efficacy. These patients have benefited 5 years, 10 years or in the case of my spouse approaching 15 years this December.

Wake up! The reality Madam Secretary is we need you to sign a formal document. Whether it is a “Compassionate Use” document or some other bureaucratic form, we need it now!

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

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Wednesday, August 13, 2014

VNS Therapy for Depression

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Wednesday, August 13, 2014 12:00 AM
To: Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services
Subject: VNS Therapy for Depression...

Dear Madam Secretary Burwell,

Once again I write to you addressing the current news regarding the spread of Ebola and the World Health Organizations position to fast tract an experimental drug and the death of Robin Williams and the fact that severe depression kills tens of thousands Americans each year brings me back to my position and advocacy that CMS is simply not doing enough for depression patients and worse yet their decision to deny medical coverage to implanted volunteer study subjects and patients already benefiting from VNS Therapy is not only unconscionable, egregious and immoral but criminal in my opinion.

While I am aware that efforts within CMS are being made to informally address and care for those Medicare/Medicaid patients who were implanted prior to the May 4, 2007 national determination to deny coverage I ask that a written document to this effect be issued to formalize their care. I also advocate for those patients covered by private health insurance carriers such as United Healthcare that continue to deny care and coverage for the same patient population. The private health insurers jumped on the May 4, 2007 decision to deny but seem to have ignored CMS recent events and the U.S. Administrative Law Judge Troy Smith’s decision.

I’ve been informed that CMS has no authority over the private health insurers but that should not preclude the fact that CEO’s of these companies should be made aware as to CMS informally providing care for the Medicare/Medicaid study subjects and patients and the recent ruling by Judge Troy Smith. Maybe an informal letter from you addressing this issue might influence Mr. Stephen J. Hemsley - CEO, United Healthcare and other insurers to change their positions as it relates to the existing VNS Therapy patients.

In my opinion that is the least you can do to share your concern for these patients trying to maintain their wellness. Do we need more individuals dying like Robin Williams? Here we have patients that have and are benefiting from a therapy only to be denied insurance coverage by their carriers. Can you not see the irony and sadness of all this bureaucratic crap?

Please, do something constructive and beneficial. Issue a “Compassionate Use” letter for the exiting patients and write an informal letter to these CEO’s. Ten minutes of your letter writing time should suffice to right these wrongs.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

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Wednesday, July 9, 2014

Important information…

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Tuesday, July 08, 2014 10:59 PM
Subject: Important Information...

To the VNS patients and their attending physicians,

1:00 PM today I participated in a teleconference with CMS. The discussion I was told is “off-the-record” although I could share one particular very important piece of information and then I’ll share my thoughts and opinions of the teleconference.

As you already know Kathleen Sebelius and Jonathan Blum had resigned their positions with their respective agencies. Ms. Amy Larrick has been moved to a higher position within CMS and will no longer be the contact person at CMS for the VNS patients so please delete any information pertaining to Amy Larrick. The first step to obtaining replacement is described in my posting link entitled:

Expediting the VNS replacement surgery for the depression patient.

Kindly substitute Courtney Turner’s name anywhere you read “Amy Larrick”. Should one encounter any obstacles then read the below listed information.

The new contact at CMS, so please mark your records accordingly, for any VNS patients for Depression initially implanted prior to May 4, 2007 is:

Ms. Courtney Turner

Telephone: 410-786-4593

Any implanted depression patient needing assistance must be prepared to supply the following information when contacting Ms. Courtney Turner:

One’s Full Name

Telephone number

State of residence

Be prepared to share any other pertinent information relating to one’s case, if requested.

I have been advised that Ms. Turner will make every effort to expedite each case on a case by case basis although some patience on the part of the applicant will also be required as Ms. Turner is apparently the sole staffer assigned to this undertaking.

I more or less firmly expressed my frustration and exasperation during the conference as to why after all this time a written or “Compassionate Use” document could not be issued, once and for all.

What I came away with is my continued belief and impression that the government is inundated with bureaucracy, upon bureaucracy, department upon department, committee upon committee and the wonderment in my mind that anything can ever be accomplished. If the government were a private enterprise in my opinion; they’d be bankrupt by now through their inefficiencies, convoluted organizational management and questionable qualification of their so called medical experts.

I also indicated during the conference call that I shall not let up in my advocacy and campaign to formally right this egregious wrong as I direct my emails to Madam Secretary Burwell in the hope she gets completely fed up with me and whether she personally signs or directs one of her subordinates to sign a formal directive to cover the health insurance for these patients.

In any event and under the circumstances I was left with the impression despite all the negatives in my mind they are making their best efforts, under the circumstances, to accommodate the medical insurance needs of the VNS Depression patients.

Sincerely,
Herb

Joyce and Herbert Stein
1008 Trailmore Lane
Weston, FL 33326-2816
(954) 349-8733
vnsdepression@gmail.com
http://www.vnstherapy-herb.blogspot.com
http://www.vnstherapy.wordpress.com

Monday, July 7, 2014

U.S. Administrative Law Judge sides with VNS Depression Patient

From: Amy [mailto:keyanote@gmail.com]
Sent: Monday, July 07, 2014 5:41 PM
To: Herbert Stein
Subject: Re: FW: VNS Therapy for Depression...

Hello, yes definitely share this. I had a phone hearing with this judge and my physician. It says he works for HHS so I would assume this is a federal decision not just the state of Indiana.

I am doing very well. Last month I had the VNS turned up so now it is at the setting is was before the impedance happened. It had to be turned up slowly. Still have up and down days but mostly good!

Herb, you saved my life. At times the only thing that kept me from taking my own life was the hope that CMS would pay for the battery changes and the surgery to correct my VNS.

If there is any other way for me to help please let me know. I attached the whole appeal judgement.

~ Amy

Tuesday, March 4, 2014

Do you remember the Terri Schiavo case?

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Tuesday, March 04, 2014 2:29 PM
To: Stephen J. Hemsley - CEO, United Healthcare
Cc: Jonathan Blum, Deputy Administrator and Director for the Center of Medicare at the Centers for Medicare and Medicaid Services; Amy Larrick, Senior Advisor to the Principal Deputy Administrator Centers for Medicare & Medicaid; President of the United States
Subject: Do you remember the Terri Schiavo case?

Dear Mr. Hemsley,

Do you remember the Teresa Marie Schindler case better known to us all as the Terri Schiavo case?

Do you remember the former Governor of Florida Jeb Bush and his brother the former President of the United States George W. Bush weighing in on the case?

Worst of all do you remember the former Senator from Tennessee Dr. Bill Frist who served on both Health and Finance committees also weighing in on the case?

All these notables individuals and one a medical professional weighing in and voicing their opinions in opposition to the patients attending physicians. What a true embarrassment was this fiasco and the fact they were all wrong.

What a truly embarrassing fiasco you and your company are now similarly causing your VNS Therapy subscriber (the patient) and her family. Despite the questionable opinions you and your company has presented the patient and her physician(s) are emphatically presenting the fact you too are wrong. The therapy in your patient’s case as that of others is not only safe, contrary to your statements, but more remarkably efficacious and beneficial to maintaining her wellness by alleviating her serious depressive mood state contrary to all the “skybox opinions” you’ve presented.

Add to the fact you’re number crunchers sitting before their computer programs are also missing the point that in the long-run VNS Therapy for depression for those patients who have in fact responded and obtained efficacy are a significant cost savings to both the health insurer and the government Medicare/Medicaid programs. Also of interest and fascination to me is the fact that United Healthcare under their Medicare managed programs has already approved and paid for the replacement surgery your private payer is now seeking and has so far been refused.

What gives? Is this not some kind of discrimination in opposition to the intent of The Mental Health Parity and Addiction Equity Act? I also remind you if by some chance you are not familiar that the very same therapy is approved and paid for by your company for Epilepsy.

In the Terri Schiavo case her physicians were rightly seeking to allow her to pass away with dignity. In this case that of a living human being by all medical definitions, her physicians, family and I are seeking to not only maintain her life but one free of pain, anguish, suffering and possible death from Major Depressive Disorder (MDD) through a treatment that has worked and benefitted the patient in the past.

Isn’t it time that you exerted your authority and demonstrated your compassion for another human being by simply ordering and rightfully replacing her depleted VNS pulse generator? Do what is morally and medically correct for this patient.

Do it now!

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

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Monday, March 3, 2014

Do we have to run a benefit for Mr. Hemsley?

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Sunday, March 02, 2014 9:13 AM
To: Stephen J. Hemsley - CEO, United Healthcare
Cc: Jonathan Blum, Deputy Administrator and Director for the Center of Medicare at the Centers for Medicare and Medicaid Services; Amy Larrick, Senior Advisor to the Principal Deputy Administrator Centers for Medicare & Medicaid
Subject: Do we have to run a benefit for Mr. Hemsley?

Dear Mr. Hemsley,

As I sit here pondering why one of the financially top paid executives in the U.S. lacks the compassion and understanding to help one of his subscribers re-obtain wellness or “Continuity of care” is beyond me. With the simple stroke of your pen or a brief telephone conversation directing one of your subordinates to make it happen you’d rather make this particular individual suffer and agonize over her future. Or do we have to run a benefit for Mr. Hemsley because 2012 was not up to his expectations?

Is it money that only rules the decision making from the skyboxes? It certainly can’t be the facts because the facts are VNS Therapy for your subscriber (the patient) after all these years is not experimental. It is not experimental as she or her attending physician would not request replacement surgery for an ineffective therapy (something I’d refer to as simple logic). It is not experimental after 14 years for my spouse or other of the long-term use patients who have obtained replacement surgery and are continuing to benefit from VNS Therapy. It is not experimental as told to your company in appeal letters that you have received from her attending physician. It is not experimental as can be told to you by all the attending physicians of those patients who have benefited from the therapy and continue to do so today.

It is successfully unique for this group of patients unlike any ineffective conventional therapy these patients have trialed over decades. VNS Therapy is unlike any of these other ineffective conventional therapies in that it truly works long-term despite the opinion of your unknowledgeable hired gun. VNS Therapy works 24/7/365 without the patient being compliant or forgetful with minimal to no side-effects for this group of patients.

Why not ask the professional opinions of the physicians attending to each and every of the patients who have chosen to continue with the VNS Therapy? You’d come up with an absolutely amazing statistic unheard of in the annals of treating patients with Major Depressive Disorder (MDD). 100% of these patients are benefiting from the therapy long-term and for continuous multiple years. No other therapy can demonstrate similar results for this patient population.

Do we really have to run a benefit for you Mr. Hemsley to make you understand after all these years VNS Therapy for these patients is not experimental. It truly is effective and benefits these formerly and severely depressed patients who have finally found relief for their illness?

Step up Mr. Hemsley and do what is morally right. In the long-term scheme of things your company will financially benefit and it will accrue to you. Give a life back to this individual!

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

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Friday, February 14, 2014

“There are doctors, good doctors and better doctors.”

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Friday, February 14, 2014 4:13 AM
To: Stephen J. Hemsley – CEO, United Healthcare; Chet Burrell, President & CEO CareFirst BlueCross BlueShield
Subject: “There are doctors, good doctors and better doctors.”

Dear Mr. Hemsley,

Now that I’ve explained how I go “Totally Bananas” every now and then and the fact I’ve been extremely busy these past nine or so days battling Joyce’s new health insurance company as it relates to her medications (another absurd and dysfunctional bureaucracy), it’s time I get back to my advocacy and battling the bureaucracy and lunacy at United Healthcare.

Along time ago I learned that when a physician hangs out his/her shingle to practice medicine it does not state whether they graduated first or last in their class. In addition, I also learned there are doctors, good doctors and better doctors. Please keep these points in mind which I shall come back to address shortly,

As part of my learning process I welcome feedback and discussion from both patients and physicians. I’ve just recently learned from a patient there is another distinguished health insurance executive who apparently gives a damn for the patient and is not blind-sided by questionable policy statements and questionable opinions from questionable physicians never having actually examined the patient.

Kudos to you Mr. Chet Burrell, President & CEO CareFirst BlueCross BlueShield and your people as I’ve learned from your private subscriber payer, formerly denied medical coverage, that your company has changed its position in respect to your subscriber. This patient just recently received approval for VNS replacement surgery from both her employer and CareFirst. This reasoned approach in this situation was to provide “continuity of care” while maintaining patient wellness is one of several reasoned factors and the rightful thing to do.

Bravo to you Mr. Burrell and your organization. Not too many of these large organizations (bureaucracies) truly care and think rationally what is both good for the patient and a long-term cost savings to the corporation.

I would like to extend my sincere appreciation to you, Mr. Burrell for doing the right thing. I’m sure the patients, physicians and government officials who receive my email distributions can also appreciate your positive and caring stance relating to these truly serious situations and ill patients.

Which now brings me back to you Mr. Hemsley and your organization at United Healthcare.

In my opinion your organization’s disingenuous and contrived response to your subscriber in denying both the patient’s initial request and first appeal as well as not comprehending the urgency letter of need as written by the patient’s highly qualified and distinguished psychiatric medical professional is truly obtuse and absurd on your company’s part. The fact that your Maureen S., Resolving Analyst was mindful in her letter of January 16, 2014 to cite (as I’ve quoted several places below) that all the supporting documents were referred to Medical Director, Amy Schneider, M.D. is most interesting and in some ways laughable, at least to me anyway. And which also brings me back to “doctors, good doctors and better doctors.”

“All of the supporting documentation was referred to a Medical Director, Amy Schneider, M.D.,

specializing in Neurology, not previously involved in this decision, for review.”

“We carefully reviewed the documentation submitted, our payment policies and the limitations,

exclusions and other terms of your Benefit Plan, including any applicable Riders, Amendments,

and Notices. We confirmed, however, that this service(s) is not eligible for payment as you

requested. You are responsible for all costs related to this service(s).

Amy Schneider, M.D., specializing in Neurology, reviewed your appeal. This decision was made

based on Vagus Nerve Stimulation 20J3TOI01 P. The determination is as follows:

Your doctor has requested coverage for a device known as a vagal nerve stimulator to treat

This feeble letter and the opinions and statement contained therein reminds me of the former Senator and doctor, Dr. Bill Frist rendering his opinion in the Terri Schiavo case. What a sad and disgraceful commentary he exhibited and offered up.

An Internet search for Amy Schneider, M.D. yields a minimum of four (4) doctors with the same name, three (3) of whom appear to practice in Arizona so I’ll presume your company’s representative is referring to Amy G. Schneider, M.D. of Scottsdale, AZ. Please correct me should I be wrong? Of additional note of interest to me when searching for Dr. Amy G. Schneider is the very lack of information pertaining to the physician. Medical Director…of what? I could find no published studies and/or papers prepared by the doctor. So please explain to me exactly what are the outstanding qualifications of Dr. Schneider to have qualified her to review and offer up an opinion in this case? Upon further search I came upon the doctor listed at a mail route in AZ and P.O. Box in Minneapolis, MN. I called the doctor at the listed telephone number and I apparently caught her off-guard. I did introduce myself and stated my full name and the fact I am Mental Health Advocate/Activist and I just wanted to learn and better understand her Curriculum Vitae and other qualifications. Boy did she clam up ever so fast. I’m curious Mr. Hemsley if you or your staff had ever reviewed the Curriculum Vitae and qualifications and/or considered asking Drs. Charles Conway or Mark George or Harold Sackeim or John A. Rush or John O’Reardon or David Dunner or Scott Aaronson or Paul Goodnick but to name only a few highly qualified and noted psychiatric practitioners their thoughts and professional opinions regarding your subscriber and/or VNS Therapy for this unique patient population?

Obviously you, your company nor Dr. Schneider noted any more recent documents and articles or took any time to read a recent finding of Dr. Charles Conway and an opinion by Dr. William Bunney which differs from Dr. Schneider’s opinions.

In reviewing your subscribers appeal and that of his/her psychiatric physicians how is it that your doctor’s opinion did not take into account in her recitation about drugs the very fact that this therapy is not a drug so why in the world does she fill the document discussing drugs? In fact it is a newer neuro-modulation therapy so your company’s lengthy diatribe about medication is simply not applicable in this situation. You too have made the very same mistake that is part of the initial controversy relating to this treatment. VNS Therapy is not a drug but a medical device. In hindsight we all can agree the studies should properly have been designed to allow for a minimum of one year study. Instead it was inappropriately based upon a protocol of a 12-week-drug-protocol. This fiasco should be a text book case study for what not to do and I am quite sure Medtronic and St. Jude took this into consideration when designing their DBS studies. So with that fact in mind it does not preclude that the therapy is either unsafe or ineffective as was faultily reasoned by Dr. Schneider. The fact is those patients who wish to continue with the therapy, i.e. your patient subscriber, has responded and obtained efficacy continuously for several years contrary to the gibberish presented and the very reason CMS has finally come to understand the benefits being derived by this implanted group of patients. The very exact same therapy you approve and pay for in epilepsy patients are also being utilized by a number depression patients and they too are benefiting. For the epilepsy patient you illogically reason it is both safe and efficacious and not so for the depression patient? Give me a break! Is that not stupidity or something close to it?

I’ll also point out to you and Dr. Schneider that 100% of the VNS depression patients wanting to continue with this therapy are both responders and obtaining long-term efficacy. Should you want to discuss statistics, this response rate and long-term efficacy is unheard of when treating this unique group of severely depressed patients. I guess this fact may also have been overlooked by both you and Dr. Schneider.

Your company pays for cross over medications approved for epilepsy that were never adequately double-blind studied for depression patients. You pay for ECT and yet there has never been any large double-blinded study approved by the FDA. Add to the fact that after many years ECT was finally acknowledged to have potential serious side-effects of cognition and memory impairment and was officially recognized in a study by Dr. Harold Sackeim.

Your recent policy decision of February 1, 2014 in my opinion is a “Swiss Cheese Policy”. One truly full of holes contrived to fill your companies political and financial objectives. The facts and realities are that some of the worst of the worst depression patients who have suffered in agony and anguish for decades after having tried all the available conventional therapies, like my spouse, and who have had numerous yearly hospitalizations have finally responded, benefited and have obtained long-term efficacy from VNS Therapy despite your irrational protestations. These individuals and their more knowledgeable attending physicians know the therapy works for their implanted patients unlike your Dr. Schneider with her Dr. Bill Frist type political and medical agenda and opinions made from afar.

I was also reminded by another of your private subscriber payers denied coverage for a VNS replacement several years ago, only at that time the opinion was written and submitted by Eugene B. Lofton M.D., Regional Medical Director. Dr. Lofton’s specialty being Internal Medicine. It seems you have propensity to hire physicians (sort of like ghost writers) whose opinions affecting people’s lives come with questionable expertise and/or credentials.

I’d make a suggestion should you ever have need for brain surgery; don’t accept the writings of a hired proctologist for his/her health care opinion.

There comes a time in one’s life that one has to be guided by one’s conscience to do what is right and just. Mr. Hemsley your time is now. You have the power and the authority like Chet Burrell to maintain the “Continuity of care” and wellness for your subscriber. Like your fellow CEO, Chet Burrell, you too can do what is right. Only do it now! There is no need for this patient to agonize, suffer and worse yet when we know there is a treatment, proven in her case history, that will alleviate her illness and set the patient on a road to recovery for you and/or your company to obstinately stand in the way of him/her achieving wellness.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

United Healthcare medical Policy Number: 2014T0101Q

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Tuesday, February 4, 2014

United Healthcare medical Policy Number: 2014T0101Q–Vagus Nerve Stimulation

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Wednesday, February 05, 2014 12:49 AM
To: Stephen J. Hemsley - CEO, United Healthcare
Cc: Jonathan Blum, Deputy Administrator and Director for the Center of Medicare at the Centers for Medicare and Medicaid Services; Amy Larrick, Senior Advisor to the Principal Deputy Administrator Centers for Medicare & Medicaid; Madam Secretary Kathleen Sebelius, United States Secretary of Health and Human Services
Subject: United Healthcare medical Policy Number: 2014T0101Q

To Joyce’s fellow VNS patients et al.,

The below listed link and attachment is United Healthcare’s recent policy as it relates to VNS Therapy.

United Healthcare has denied replacement surgery to an existing VNS Therapy depression patient and then subsequently also denied the patients first appeal. The patient is now working on a second appeal.

Yet United Healthcare’s Medicare Advantage PPO program paid for two (2) patient replacements, one of those being my spouse Joyce. At the time United Healthcare’s representative floundered over me to insure that Joyce’s surgery and needs were all taken care of for which I was most appreciative (and thank you too Amy Larrick, CMS). Now we have United Healthcare’s reversal of care toward a private subscriber payer.

The decision on the part of United Healthcare and it’s CEO is truly an abomination as well as cruel and goes against CMS informal decision of September 26, 2013. The lack of humanism and compassion for this patient is unfathomable. The denial overlooks and does not take into account the most important fact of all; the patient maintained wellness for multiple years and now that the battery has depleted the patient is slipping back into the abyss of a major depressive episode. This fact, in the case of this patient as well as other existing VNS Therapy depression patients wishing to continue with their therapy contradicts a number of the assessments contained in the United Healthcare medical Policy Number: 2014T0101Q.

“UnitedHealthcare reserves the right, in its sole discretion, to modify its Policies and Guidelines as necessary. This Medical Policy is provided for informational purposes. It does not constitute medical advice.”

Just quickly, what I find of interest right-off-the-bat in this policy is the fact it does not indicate who prepared this policy. Was it some bureaucrat or youngster sitting in front of a computer making this determination? Was it a medical professional(s)? More importantly, was it a medical professional(s) with psychiatric credentials and/or certification? Was it one of the notorious ghost writers often found preparing research study results or documents of this nature? Then there is the fact that “UnitedHealthcare reserves the right, in its sole discretion, to modify its Policies and Guidelines as necessary. This Medical Policy is provided for informational purposes. It does not constitute medical advice.” And yet United Healthcare totally disregards the patient’s highly qualified psychiatric medical professional’s statements as to why the patient requires this therapy.

There will be more to follow as I gather my thoughts and share my facts and opinions based upon what I consider a subjective and flawed policy lacking true understanding of the nature of Major Depressive Disorder (MDD) as explained in United Healthcare medical Policy Number: 2014T0101Q. The fact the policy discriminates against patients who have obtained multiple-years of wellness and require access to replacement and care to maintain their mental health, general wellbeing and reasonable quality of life goes beyond reason and logic.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

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Friday, January 31, 2014

"Joyce, please wait. I'm expecting an important call and then we'll go shopping."

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Friday, January 31, 2014 11:00 AM
To: Stephen J. Hemsley - CEO, United Healthcare; Chet Burrell, President & CEO CareFirst BlueCross BlueShield
Cc: Jonathan Blum, Deputy Administrator and Director for the Center of Medicare at the Centers for Medicare and Medicaid Services; Amy Larrick, Senior Advisor to the Principal Deputy Administrator Centers for Medicare & Medicaid
Subject: "Joyce, please wait. I'm expecting an important call and then we'll go shopping."

To Joyce’s fellow VNS Therapy patients et al,

Apparently and once again my efforts, advocacy as well as my emails are not going unread nor unheeded.

"Joyce, please wait. I'm expecting an important call and then we'll go shopping," was my response to Joyce as I shared quick emails (see below) with Mr. Jonathan Blum, Deputy Administrator and Director for the Center of Medicare at the Centers for Medicare and Medicaid Services.

In my “off-the-record” telephone conversation yesterday at about 3:00 PM with Jonathan he wanted to let me know my messages are all being read as well as some additional information he wanted to share.

Once again I can only share my understanding and interpretation of what was discussed without quoting directly.

I feel strongly based upon Jonathan’s word and what his agency have already effectively done for a number of the VNS Medicare/Medicaid patients that they are endeavoring to somehow continue by also assisting the private pay patients. I gathered from the conversation what I’ve come to know that these are very large government agencies guided by rules, regulations and protocols and that it may take a little time to reach our objective. As an analogy I would liken it to steering a huge oil tanker; they can’t turn on a dime and it takes considerable advanced planning and preparation to steer left or right. In my opinion, hopefully we shall get there but I’m unable to put a frame on the matter.

In the meantime I shall continue my advocacy and focus toward the two current CEO’s where I’ve been told by the patients that have communicated with me that their companies have declined private payer(s). I do so in the hope these executives will come to understand the seriousness and potentially deadly consequences of inaction and/or denial and the need for compassion, humanism and doing the right thing. As a former CEO of a considerably smaller business enterprise I had the authority and ability to make things happen quickly as I am sure so do Mr. Stephen Hemsley, CEO, United Healthcare and Mr. Chet Burrell, President & CEO CareFirst BlueCross BlueShield.

I ask these gentlemen to please make things favorably happen for your existing VNS patients who require replacement without having to wait for any formal government document and/or communication to effectuate this process and/or policy within your organizations. Inaction or denial may well prove fatal to some of these patients who otherwise were doing well.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

“HHS Operating Divisions are responsible for implementing programs that touch the lives of all Americans. Whether it’s providing millions of children, families, and seniors with access to high-quality health care, helping people find jobs and parents find quality child care, keeping the food on Americans’ shelves safe and infectious diseases at bay, or exploring new frontiers of biomedical research, we are working every day to give Americans the building blocks they need to live healthy, successful lives.”

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NOTICE OF CONFIDENTIALITY / Disclaimer

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From: Blum, Jonathan D. (CMS/CM) [mailto:Jonathan.Blum@cms.hhs.gov]
Sent: Thursday, January 30, 2014 2:44 PM
To: Herbert Stein
Subject: RE: What is it that you and your agency doesn't understand?

I will call you in a few minutes.

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Thursday, January 30, 2014 2:42 PM
To: Blum, Jonathan D. (CMS/CM)
Subject: RE: What is it that you and your agency doesn't understand?

Jonathan,

Any chance of calling right now? Home 954-349-8733

Herb

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NOTICE OF CONFIDENTIALITY / Disclaimer

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From: Blum, Jonathan D. (CMS/CM) [mailto:Jonathan.Blum@cms.hhs.gov]
Sent: Thursday, January 30, 2014 2:39 PM
To: Herbert Stein
Subject: RE: What is it that you and your agency doesn't understand?

Mr. Stein: is there a good time to give you a call today? If so, let me know the right number.

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Thursday, January 30, 2014 12:12 PM
To: Sebelius, Kathleen (HHS/OS)
Cc: Blum, Jonathan D. (CMS/CM); Larrick, Amy (CMS/CM); Stephen J. Hemsley - CEO, United Healthcare; Chet Burrell, President & CEO CareFirst BlueCross BlueShield
Subject: What is it that you and your agency doesn't understand?

Dear Madam Secretary Sebelius,

Are you so beyond reproach that after numerous emails to you that you lack the common decency and courtesy of an acknowledgement or response from either you or one of your subordinates? Is such a response also beyond your humanism and the scope of your position, agency or mission?

I write to you not asking anything for myself but I do so on behalf of seriously ill patients. I do so because CMS, one of the agencies under your domain seriously screwed up. I do so because their screw up was egregious, unconscionable, immoral and obviously lacking much wisdom and foresight.

The FDA, approves a therapy. Then two years later another agency under your dominion, CMS, denies medical coverage for an FDA approved therapy and from my understanding the first time such an event took place. The health insurance industries follows CMS lead and denies coverage to their subscribers. We are then left with implanted medical devices in volunteer study subjects and patients who obtained the therapy as study subjects or by way of their insurance coverage during the two year gap between FDA approval and CMS denial. Absolutely brilliant thinking on the part of our convoluted government agencies and its voluminous staff of administrators and so called expert personnel (stated sarcastically).

It is almost 7 years from the date CMS first denied coverage. To correct this blatant oversight CMS has apparently understood the gravity and seriousness of this error and/or oversight and has partially corrected the situation by issuing a “Stealth Decision”. CMS has acted responsibly and is caring for these patients but the private health insurers have not followed suit.

I did learn from CMS that they have no authority over the private health insurance carriers. I can understand and accept the scope of their authority. What I can’t accept is the fact I requested CMS, Ms. Amy Larrick, to please call the private health insurance carriers or to write to them explaining their recent reversal decision to care for all the Medicare/Medicaid patients needing help for all those implanted on or prior to their previous denial date of May 4, 2007. It was further explained to me that a meeting was held within CMS and the decision was made that they would not call or write. What I also cannot accept or fathom, i.e. United Healthcare managed Medicare programs have paid for patient replacement and care and the same company has denied care to private payers? How is that possible and not a violation of the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA)? Does this not smack of discrimination?

Is there not anyone within your various agencies that can fully grasp the seriousness of what is transpiring?

What you also may be lacking in your knowledge and wisdom is the fact these patients responded and obtained efficacy from VNS Therapy for multiple years and now that their pulse generators (batteries) are depleting they are returning to the abyss of depression, despair and agony and suicidal ideations. How in good conscience can you or anyone reading my missives still sit by and do nothing when we know there is an effective treatment being denied these patients. Too boot, there is a substantial cost savings not only to the government but the insurance carriers as well in maintaining their long-term wellness. Add to the fact a number of these patients have been able to maintain employment, pay taxes and are now facing losing both their wellness and employment.

Therefore, my goal of having health insurers change their policy toward these patients has only partially been achieved and my reason for hounding you and your agency to act responsibly and now!

You “are working every day to give Americans the building blocks they need to live healthy, successful lives.” Oh really, you’ve fooled me. I couldn’t tell by your total lack of response, concern or effort for this small group of seriously ill patients.

I know little about the bureaucracy of your agency or for that matter the workings of any government agency other than to opine that I am truly amazed that anything worthwhile or effective ever seems to be accomplished. I also question whether you or any of your staff take the time to read what you publish on your webpages. If so then you would know and understand that I am not asking for anything outrageous or beyond the scope of your agencies capabilities.

I am again asking you to please notify the private health insurance carriers of CMS policy change in their “Stealth Decision” as it relates to this unique group of seriously ill patients. Do what is right only do it now!

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

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NOTICE OF CONFIDENTIALITY / Disclaimer

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Thursday, January 30, 2014

What is it that you and your agency doesn't understand?

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Thursday, January 30, 2014 12:12 PM
To: Madam Secretary Kathleen Sebelius, United States Secretary of Health and Human Services
Cc: Jonathan Blum, Deputy Administrator and Director for the Center of Medicare at the Centers for Medicare and Medicaid Services; Amy Larrick, Senior Advisor to the Principal Deputy Administrator Centers for Medicare & Medicaid; Stephen J. Hemsley - CEO, United Healthcare; Chet Burrell, President & CEO CareFirst BlueCross BlueShield
Subject: What is it that you and your agency doesn't understand?

Dear Madam Secretary Sebelius,

Is there not anyone within your various agencies that can fully grasp the seriousness of what is transpiring?

Therefore, my goal of having health insurers change their policy toward these patients has only partially been achieved and my reason for hounding you and your agency to act responsibly and now!

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

http://www.hhs.gov/about/

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NOTICE OF CONFIDENTIALITY / Disclaimer

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Wednesday, January 29, 2014

"It was once said that the moral test of government is how that government treats...those who are in the shadows of life, the sick, the needy and the handicapped."

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Wednesday, January 29, 2014 7:47 AM
To: Madam Secretary Kathleen Sebelius, United States Secretary of Health and Human Services
Cc: Jonathan Blum, Deputy Administrator and Director for the Center of Medicare at the Centers for Medicare and Medicaid Services; Amy Larrick, Senior Advisor to the Principal Deputy Administrator Centers for Medicare & Medicaid; Stephen J. Hemsley - CEO, United Healthcare; Chet Burrell, President & CEO CareFirst BlueCross BlueShield
Subject: "It was once said that the moral test of government is how that government treats...those who are in the shadows of life, the sick, the needy and the handicapped."

Dear Madam Secretary Sebelius,

Yesterday I received an email response from my son-in-law in regards to the previous email I sent to you entitled “The Buck Stops here!” in which he said,

“When are you throwing your hat into the Gubernatorial race?

I'll move down there to vote for you. ”

I in turn replied to my son-in-law,

“I thought I was done with this until the last two weeks when I got four requests for help both from patients and doctors.

The bureaucracy and crap that goes on in DC is unfathomable. It is truly amazing anything ever gets done in this country.

I’d just like to retire to some peace and quiet.”

I should have properly stated “I’d just like to retire once again to some peace and quiet”.

The advocating for the VNS Therapy depression volunteer study subjects expanded to include all the implanted VNS depression medical device patients who were short changed by the sponsor (Cyberonics), the FDA, CMS and all the medical professionals who established the original protocols for these studies and through subsequent implants after the FDA approval through their oversight to provide medical care for these patients. Honestly Madam Secretary while you did look resplendent in your blue suit this past evening I would like to retire once again knowing you took proper care of these patients.

What started as a self-serving cause for me to obtain health insurance coverage for my spouse grew into an advocacy for a small group of VNS Therapy depression patients. These patients are responding and obtaining efficacy, as is my spouse, as never before while also achieving a reasonable quality of life for themselves. The FDA approved this therapy for both Epilepsy and Depression. CMS early on only approved the therapy for epilepsy while denying coverage for depression and only up until recently in their “Stealth decision” have they issued an approval for depression. What remains is to overcome the denials and discrimination on the part of a number health insurance carriers and the reason I am looking to you to rectify the balance of this outrageous injustice.

Next to your mission statement on your webpage is a quote:

The patients for whom I advocate are “…those who are in the shadows of life, the sick, the needy and the handicapped.”

I truly hope this quote and the words contained therein, you and your agency adhere to and act upon and is not posted on your site to look pretty and simply fill space on a webpage. Your fellow Americans need your help; now!

It is time for you to respond and finally act responsibly and exhibit leadership on behalf of these sick patients. Please issue a communication (mandate, directive and/or some piece of paper) to all the health insurance industry to morally and rightfully cover these patient subscribers and not discriminate in any manner against this mental health group in their dire need for care.

Please truly treat these patients (your fellow Americans) with respect and care that they deserve and in doing so allow me to return to my retirement, once again, so that I may better care for my spouse.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733